Abstract: The invention provides devices with integrated intravascular imaging and methods for crossing a CTO within the true lumen of a vessel. An interventional catheter with intravascular imaging capabilities can be guided into an affected vessel and to a CTO. An included intravascular imaging device captures a 3D image of the environment. The catheter includes a crossing member that can be extended out from a distal tip of the catheter, causing the crossing member to directly cross through the CTO creating a new channel through the CTO.

Abstract: An intravascular imaging device is provided. In one embodiment, the intravascular imaging device includes a flexible elongate member sized and shaped for insertion into a vessel of a patient, the flexible elongate member having a proximal portion and a distal portion; a conductor extending between the proximal and distal portions of the flexible elongate member; an imaging assembly disposed at the distal portion of the flexible elongate member, the imaging assembly including: a flex circuit including a body and a tab extending therefrom, the tab having a conductive portion coupled to the conductor; and a support member around which the flex circuit is disposed, the support member including a shelf on which tab is positioned.

Abstract: An intraluminal imaging device includes a flexible elongate shaft including a distal portion and a proximal portion, wherein the flexible elongate shaft is configured for insertion into a patient body; a distal tip that comprises an imaging element and is operably associated with the distal portion of the flexible elongate shaft; and a control handle coupled to the proximal portion of the flexible elongate shaft, wherein the control handle includes: a first actuator configured to position the imaging element within the patient body; and a first frictional member coupled to the first actuator and arranged to contact the first actuator to control positioning of the imaging element. Associated devices, systems, and methods are also provided.

Abstract: An imaging catheter assembly is provided. In one embodiment, the imaging catheter assembly includes a flexible elongate member including a distal portion and a proximal portion; a crown element coupled to the distal portion, wherein the crown element includes an annular ring, a first post and, a second post, and wherein the first post and the second post extend from the annular ring; a first pullwire anchored to the annular ring at the first post and extending along the flexible elongate member from the crown element to the proximal portion of the flexible elongate member; a second pullwire anchored to the annular ring at the first post and extending along the flexible elongate member from the crown element to the proximal portion of the flexible elongate member; and an imaging component coupled to the distal portion.

Abstract: An intraluminal imaging device includes a flexible elongate shaft including a distal portion and a proximal portion, wherein the flexible elongate shaft is configured for insertion into a patient body; a distal tip that comprises an imaging element and is operably associated with the distal portion of the flexible elongate shaft; and a control handle coupled to the proximal portion of the flexible elongate shaft, wherein the control handle includes: a first actuator configured to position the imaging element within the patient body; and a first frictional member coupled to the first actuator and arranged to contact the first actuator to control positioning of the imaging element. Associated devices, systems, and methods are also provided.

Abstract: An intravascular imaging device (102) is provided. In some embodiments, the intravascular imaging device includes a flexible elongate member sized and shaped for insertion into a vessel of a patient, the flexible elongate member having a proximal portion and a distal portion; and an imaging assembly (110) disposed at the distal portion of the flexible elongate member, the imaging assembly including a flex circuit (214) positioned directly around the flexible elongate member. In some embodiments, a method of assembling an intravascular imaging device includes obtaining a flex circuit including a first layer having a plurality of transducers and a second layer having an acoustic backing material; and positioning the flex circuit directly around a distal portion of a flexible elongate member.

Abstract: Systems, devices, and methods provide a solid-state intravascular ultrasound (IVUS) imaging system that includes an array of ultrasound transducers mounted on a structural uni-body made of a polymeric substance doped with acoustic dampening material. The use of the polymeric substance doped with acoustic dampening material to fabricate the uni-body assists in improving the signal-to-noise ratio associated with the IVUS imaging signals.

Abstract: An intravascular imaging device is provided. In one embodiment, the intravascular imaging device includes a flexible elongate member sized and shaped for insertion into a vessel of a patient, the flexible elongate member having a proximal portion and a distal portion; an imaging assembly disposed at the distal portion of the flexible elongate member, the imaging assembly including: a flex circuit; a conductor extending along the flexible elongate member and in electrical communication with the flex circuit; and a support member around which the flex circuit is positioned, the support member including a conductive portion electrically coupled to the support member.

Abstract: Handheld steering devices for use with intravascular devices and associated systems and methods are disclosed. In some instances, the handheld steering device includes a housing sized and shaped for grasping by a hand of a user, the housing including a proximal portion and a distal portion, wherein the distal portion includes an opening sized and shaped to receive an intravascular device; an adaptor positioned within the opening of the housing, the adaptor including a bore sized and shaped to allow a proximal end of the intravascular device to pass therethrough; a steering controller coupled to the housing; and an actuator positioned within the housing and in communication with the steering controller, the actuator interfacing with the proximal end of the intravascular device based on inputs to the steering controller to steer a distal end of the intravascular device. Associated systems and methods are also disclosed.

Abstract: Intraluminal imaging devices and methods of assembling the intraluminal imaging devices are provided. For example, an intraluminal imaging device can include a flexible elongate catheter body and a rigid imaging assembly coupled to a distal portion of the elongate catheter body. A distal portion of the inner member is positioned within a lumen of the imaging assembly, and the flexible elongate member comprises a strain relief layer positioned around the inner member. A distal portion of the strain relief layer is positioned radially between the inner member and the imaging assembly, and a proximal end of the strain relief layer is positioned distally of a proximal end of the inner member, forming a transition region. The transition region can prevent bending or kinking of the flexible elongate catheter body when the intraluminal imaging device is navigating tortuous regions of the patient's anatomy.

Abstract: An imaging catheter assembly is provided. In one embodiment, the imaging catheter assembly includes a flexible elongate member comprising a distal portion and a proximal portion; a tip member coupled to a distal end of the distal portion of the flexible elongate member, wherein the tip member includes a tubular body comprising a closed distal end, an opened proximal end, and a proximal curved top outer wall extending from the proximal opened end and tapering into a distal flat top outer wall towards the closed distal end; and an imaging component mounted within the tip member. In one embodiment, the imaging catheter assembly includes a flexible elongate member; a tip member coupled to a distal end of the flexible elongate member, wherein the tip member includes a cylindrical body and a uniform outer diameter; and an imaging component mounted within the tip member.

Abstract: An intraluminal imaging device includes a flexible elongate member configured to be positioned within a body lumen of a patient, the flexible elongate member comprising a proximal portion and a distal portion; an ultrasound imaging assembly disposed at the distal portion of the flexible elongate member, the ultrasound imaging assembly comprising: a flexible substrate comprising: a proximal portion comprising a plurality of recesses extending completely through the flexible substrate from a first surface to an opposite, second surface; and a distal portion comprising a plurality of acoustic elements; a support member around which the distal portion of the flexible substrate is positioned; and a plurality of conductors extending along a length of the flexible elongate member and coupled to the proximal portion of the flexible substrate such that the plurality of conductors are in communication with the plurality of acoustic elements.

Abstract: A method of assembling an intravascular imaging device is provided. In one embodiment, the method includes obtaining a support member having a body portion including a plurality of recesses longitudinally spaced from one another; positioning a flex circuit around the support member such that the flex circuit is radially spaced from the body portion of the support member; and filling a space between the flex circuit and the support member with a backing material through the plurality of recesses of the body portion. In one embodiment, an intravascular imaging device includes a flexible elongate member; an imaging assembly including: a flex circuit; and a support member around which the flex circuit is disposed, the support member having a body portion including plurality of recesses, wherein the support member defines lumen in fluid communication with a space between the flex circuit and the support member via the plurality of recesses.

Abstract: The present invention generally relates to a rapid exchange configuration that reduces the profile of a catheter riding on a guidewire and minimizes guidewire resistance. According to certain embodiments, a body of the catheter includes a distal portion and a proximal portion. The distal portion defines a guidewire lumen and includes a guidewire exit port being open in an proximal direction and leading to the guidewire lumen. A proximal section of the guidewire lumen is straight.

Abstract: An intravascular imaging device is provided. In one embodiment, the intravascular imaging device includes a flexible elongate member sized and shaped for insertion into a vessel of a patient, the flexible elongate member having a proximal portion and a distal portion; an imaging assembly disposed at the distal portion of the flexible elongate member, the imaging assembly including: a flex circuit; a conductor extending along the flexible elongate member and in electrical communication with the flex circuit; and a support member around which the flex circuit is positioned, the support member including a conductive portion electrically coupled to the support member.

Abstract: A method of assembling an intravascular imaging device (102) is provided. In one embodiment, the method includes obtaining a support member having a body portion including a plurality of recesses longitudinally spaced from one another (405); positioning a flex circuit around the support member such that the flex circuit is radially spaced from the body portion of the support member (410); and filling a space between the flex circuit and the support member with a backing material through the plurality of recesses of the body portion (420). In one embodiment, an intravascular imaging device includes a flexible elongate member; an imaging assembly including: a flex circuit; and a support member (330) around which the flex circuit is disposed, the support member having a body portion including plurality of recesses (339), wherein the support member defines lumen in fluid communication with a space between the flex circuit and the support member via the plurality of recesses.

Abstract: Handheld steering devices for use with intravascular devices and associated systems and methods are disclosed. In some instances, the handheld steering device includes a housing sized and shaped for grasping by a hand of a user, the housing including a proximal portion and a distal portion, wherein the distal portion includes an opening sized and shaped to receive an intravascular device; an adaptor positioned within the opening of the housing, the adaptor including a bore sized and shaped to allow a proximal end of the intravascular device to pass therethrough; a steering controller coupled to the housing; and an actuator positioned within the housing and in communication with the steering controller, the actuator interfacing with the proximal end of the intravascular device based on inputs to the steering controller to steer a distal end of the intravascular device. Associated systems and methods are also disclosed.

Abstract: The present invention generally relates to a rapid exchange configuration that reduces the profile of a catheter riding on a guidewire and minimizes guidewire resistance. According to certain embodiments, a body of the catheter includes a distal portion and a proximal portion. The distal portion defines a guidewire lumen and includes a guidewire exit port being open in an proximal direction and leading to the guidewire lumen. A proximal section of the guidewire lumen is straight.

Abstract: An intraluminal imaging device includes a flexible elongate shaft including a distal portion and a proximal portion, wherein the flexible elongate shaft is configured for insertion into a patient body; a distal tip that comprises an imaging element and is operably associated with the distal portion of the flexible elongate shaft; and a control handle coupled to the proximal portion of the flexible elongate shaft, wherein the control handle includes: a first actuator configured to position the imaging element within the patient body; and a first frictional member coupled to the first actuator and arranged to contact the first actuator to control positioning of the imaging element. Associated devices, systems, and methods are also provided.

Abstract: An imaging catheter is provided. In one embodiment, the imaging catheter includes a flexible elongate member that includes a proximal portion formed of a first material embedded with a first braid with a first braid pitch; a distal portion formed of a second material embedded with a second braid with a second braid pitch, wherein the second material is a lower durometer than the first material and wherein the second braid pitch is a higher per inch count than the first braid pitch such that the distal portion is more flexible than the proximal portion; a primary lumen extending between the proximal portion and the distal portion; and a plurality of secondary lumens extending between the proximal portion and the distal portion; and an imaging component coupled to the distal portion of the flexible elongate member.